The Biostatistics Core (Core B) will provide biostatistical expertise in the design, conduct and analysis of the clinical trials, animal studies and related research projects generated under this proposal. The goals of the Core are to provide biostatistical support to the six projects at all phases of the research. Core staff will consult with investigators prior to the initiation of studies to review study objectives and assist in selecting efficient designs and sample sizes that will provide adequate power to address the objectives. For clinical studies, a Core member will conduct a protocol review with investigators and assist in protocol development, sample size determination, plans for interim analyses, and if applicable, randomization. Core staff will perform statistical analyses and data exploration for POI investigators using appropriate statistical methodologies; prepare reports of results; assist with the preparation of presentations and writing of statistical components of manuscripts; and consult on the design of subsequent research. The Core director has widespread experience in applied and methodologic statistical research, which will allow for the most appropriate methodologies to be utilized as well as for modification or development of new methods if needed.